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| ID | Type | Description | Link |
|---|---|---|---|
| LX7101.101 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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This Phase 1/2a study is intended to assess the safety, tolerability, and effects on intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose LX7101 | Experimental | Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye) |
|
| High dose LX7101 | Experimental | Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye) |
|
| LX7101 Vehicle | Placebo Comparator | Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX7101 (0.125%) | Drug | Subjects will receive 0.125% LX7101 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing an adverse event | 15 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) in the study eye | Days 1, 3, 7, 10, 14, 15 | |
| Best Corrected Visual Acuity (BCVA) | Days 1, 3, 7, 10, 14, 15 | |
| Slit lamp biomicroscopy exam (SLE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Freiman, M.D., MPH | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Morrow | Georgia | 30260 | United States | ||
| Lexicon Investigational Site |
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| LX7101 (0.25%) |
| Drug |
Subjects will receive 0.25% LX7101 |
|
| LX7101 Vehicle | Drug | Subjects will receive vehicle |
|
| Days 1, 3, 7, 10, 14, 15 |
| Memphis |
| Tennessee |
| 38119 |
| United States |
| Lexicon Investigational Site | Austin | Texas | 78731 | United States |
| Lexicon Investigational Site | Houston | Texas | 77025 | United States |
| Lexicon Investigational Site | San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000607841 | LX-7101 |
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